CAJ | 학술논문

目的：评价 Evolocumab 降低低密度脂蛋白胆固醇(low density lipoprotein cholesterol,LDL-C)的有效性及安全性。方法通过电子数据库检索所有评价 Evolocumab 治疗高 LDL-C 的随机对照研究,采用 RevMan5.2软件对数据进行 Meta 分析。结果一共纳入5项前瞻性随机对照研究,包括1396个病例。Meta 分析结果显示：与安慰剂比较,Evolocumab 可显著降低 LDL-C(WMD=-55.04,95% CI =-57.45~-52.62,P <0.05)。两组在治疗后转氨酶升高大于3倍正常值上限(OR =0.57,95% CI =0.20~1.61)、肌酸激酶升高大于5倍正常值上限(OR =2.52,95% CI =0.63~10.00)、严重不良事件(OR =1.49,95% CI =0.82~2.73)、因药物不良事件导致停药(OR =1.17,95% CI =0.51~2.72)发生等方面差异均无统计学意义(P >0.05)。结论现有临床试验数据表明, Evolocumab 降低 LDL-C 是安全有效的。
목적：평개 Evolocumab 강저저밀도지단백담고순(low density lipoprotein cholesterol,LDL-C)적유효성급안전성。방법통과전자수거고검색소유평개 Evolocumab 치료고 LDL-C 적수궤대조연구,채용 RevMan5.2연건대수거진행 Meta 분석。결과일공납입5항전첨성수궤대조연구,포괄1396개병례。Meta 분석결과현시：여안위제비교,Evolocumab 가현저강저 LDL-C(WMD=-55.04,95% CI =-57.45~-52.62,P <0.05)。량조재치료후전안매승고대우3배정상치상한(OR =0.57,95% CI =0.20~1.61)、기산격매승고대우5배정상치상한(OR =2.52,95% CI =0.63~10.00)、엄중불량사건(OR =1.49,95% CI =0.82~2.73)、인약물불량사건도치정약(OR =1.17,95% CI =0.51~2.72)발생등방면차이균무통계학의의(P >0.05)。결론현유림상시험수거표명, Evolocumab 강저 LDL-C 시안전유효적。
Objective To evaluate the efficacy and safety of Evolocumab for lowering low density lipoprotein cholesterol (LDL-C ). Methods Electronic databases were searched to identify all randomized controlled trials comparing Evolocumab and palcebo for hypercholesterolaemia patients.Software RevMan 5.2 was utilized to perform Meta analysis.Results The study enrolled five studies including 1 396 patients.Compared with the placebo group, Evolocumab reduced LDL-C significantly (WMD=-55.04,95% CI =-57.45-52.62,P <0.05 ).But,two groups showed similarities in the incidence rates (OR = 0.57,95% CI = 0.20-1.61 )of transaminase > 3 upper limits of normal (ULN),creatinine kinase >5 ULN (OR =2.52,95% CI =0.63-10.00),severe adverse event (OR =1.49, 95% CI =0.82-2.73,P =0.1 9),discontinuation of investigational product due to adverse event (OR =1.1 7,95% CI=0.5 1-2.72)(P >0.05).Conclusion This meta-analysis suggests that Evolocumab is effective and safe for patients with hypercholesterolaemia.